diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: walgreen company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler walgreen company
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Walgreen Company

Identifiers & Regulatory

Product NDC 0363-8350
Product ID 0363-8350_1134343b-ae9d-7a46-e063-6394a90a9e43
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2022-08-12

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03638350
Hyphenated Format 0363-8350

Supplemental Identifiers

RxCUI
1049909
UNII
TC2D6JAD40

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diphenhydramine hydrochloride (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0363-8350-01) / 100 CAPSULE in 1 BOTTLE
  • 600 CAPSULE in 1 BOTTLE (0363-8350-02)
  • 365 CAPSULE in 1 BOTTLE (0363-8350-06)
source: ndc

Packages (3)

0363-8350-01 1 BOTTLE in 1 CARTON (0363-8350-01) / 100 CAPSULE in 1 BOTTLE 0363-8350-02 600 CAPSULE in 1 BOTTLE (0363-8350-02) 0363-8350-06 365 CAPSULE in 1 BOTTLE (0363-8350-06)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Diphenhydramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1134343b-ae9d-7a46-e063-6394a90a9e43", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["d9f650b5-3c27-17cf-e053-2995a90af48a"], "manufacturer_name": ["Walgreen Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-8350-01)  / 100 CAPSULE in 1 BOTTLE", "package_ndc": "0363-8350-01", "marketing_start_date": "20240202"}, {"sample": false, "description": "600 CAPSULE in 1 BOTTLE (0363-8350-02)", "package_ndc": "0363-8350-02", "marketing_start_date": "20221017"}, {"sample": false, "description": "365 CAPSULE in 1 BOTTLE (0363-8350-06)", "package_ndc": "0363-8350-06", "marketing_start_date": "20220812"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "0363-8350_1134343b-ae9d-7a46-e063-6394a90a9e43", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0363-8350", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Walgreen Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220812", "listing_expiration_date": "20261231"}